Events

Rappel de Device Recall Life Pulse High Frequency Ventilator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Bunnell, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63710
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0514-2013
  • Date de mise en oeuvre de l'événement
    2012-11-19
  • Date de publication de l'événement
    2012-12-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114595
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Ventilator, high frequency - Product Code LSZ
  • Cause
    Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. bunnell is recalling all lots of circuits distributed between march 12, 2012 and november 30, 2012.
  • Action
    On 12/5/12, the firm, Brunnell, Inc., issued a public press notification to their consignees. A. On or before 12-12-2012 a certified letter will be sent to all customer listed in the customer database. Specifically each customer will receive two certified letters; one directed to Director of Respiratory Therapy and a second to the Director of Biomedical Engineering. The certified letter will contain a copy of the Recall Noticeand a copy of the Certificate of Medical Necessity. The Certified Letter receipts will be maintained. On the mailing date a copy of the Recall Notice will be placed on the Bunnell website. B. An Excel database will be maintained for each customer/lot #. The database will contain the current status for each. Included will be: 1. Customer Information 2. Date Certified Letter Sent 3. Date receipt received and filed 4. Date product returned or that no stock remains 5. Lot number & Quantity C. On or before 02-01-2013, a second letter will be sent to those customers who have not responded to the original certified letter. D. Data will be maintained in the database E. On or before 04-01-2013, a phone call will be placed to those customers who have not responded to either of the letters. F. Data will be maintained in the database G. On or before 04-15-2013, a second phone call will be placed to those customers who have not responded to the letters or previous phone call. H. Data will be maintained in the database I. On or before 06-07-2013, a Final Recall Notification certified letter will be sent to those customers who have not responded to either of the previous letters or phone calls. J. The Certified Letter receipt will be maintained K. Data will be maintained in the database L. When PMA for alternate heater wire is approved, steps A-K will be repeated. Dates will be determined. M. Following completion of Step L, a final review of the database will occur. Final tabulation of the status for each custo

Device

Device Recall Life Pulse High Frequency Ventilator
  • Modèle / numéro de série
    Patient Circuit (catalog # 902) lot # on each individual patient circuit label: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371, 12I397, 12J413, 12J430, 12J448, 12K457, 12K471 Patient Circuit Kit (catalog # 397) lot # on the label on outside of box: 12C099, 12C114, 12C124, 12C135, 12D152, 12D170, 12D188, 12E203, 12E210, 12E223, 12F238, 12F255, 12F274, 12G209, 12G280, 12H334, 12H341, 12I356, 12I369, 12I392, 12J411, 12J425, 12J447, 12K467, 12K479
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).
  • Description du dispositif
    Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. || Model #(s): || Individual Patient Circuit - catalog # 902 || Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. || Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. || Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
  • Manufacturer
    Bunnell, Inc.

Manufacturer

Bunnell, Inc.
  • Adresse du fabricant
    Bunnell, Inc., 436 Lawndale Dr, Salt Lake City UT 84115-2917
  • Source
    USFDA